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Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine (CD)

Primary Purpose

Cannabis Dependence

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis Dependence focused on measuring Quetiapine, Psychotic experiences, Cannabis dependence, Craving, Mood, Substance use

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • DSM-IV-defined diagnosis of cannabis dependence (304.30) assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998))
  • one or more attenuated positive symptoms with a score 3 ('moderate'), 4 ('moderate severe'), or 5 ('severe but not psychotic') during the past year assessed with the Structured Interview for Prodromal Syndromes (SIPS) and the Scale of Prodromal Symptoms (SOPS) (McGlashan et al, 2001)
  • lifetime treatment with antipsychotic medication less than 2 weeks
  • cannabis use for more than one year
  • cannabis use three or more days per week on average for the past 3 months
  • aged 18 to 65
  • competent and willing to sign informed consent
  • for women, a negative urine pregnancy test and agreement to use a medically accepted method of birth control during the study.

Exclusion Criteria:

  • DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, a psychotic disorder due to a general medical condition, psychosis NOS, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998)
  • DSM-IV diagnosis of any psychoactive substance dependence other than cannabis or nicotine
  • being in an environment with no access to cannabis (e.g., hospitalization, residential treatment, jail, ..) for more than one week during the past three months preceding study entry
  • serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain
  • use of medications that have an effect on monoamines (e.g., antidepressants
  • severe medical or physical illnesses
  • criteria of the National Cholesterol Education Program (NCEP) for a metabolic syndrome (Expert panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, 2001)
  • medical condition that requires treatment with a medication that has psychotropic effects
  • significant risk of suicidal or homicidal behavior
  • cognitive or language limitations, or any other factor that would preclude subjects providing informed consent or participating in study procedures
  • treatment with medications for addiction
  • treatment with medication having a risk of addiction (e.g., benzodiazepines, barbiturates)
  • history of treatment resistance to quetiapine ER
  • medical contraindications to quetiapine ER
  • hypersensitivity to quetiapine ER or any of its component
  • for women, pregnant, breastfeeding, or intention to become pregnant during the study timeframe

Sites / Locations

  • The Zucker Hillside Hospital
  • General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Quetiapine ER

Arm Description

Outcomes

Primary Outcome Measures

Frequency/amount of substance use
frequency and amount of cannabis and other substance use will be recorded with the Timeline Follow-Back Method.
Psychotic symptoms
Psychotic symptoms wil be assessed with the Structured Interview for Prodromal Symptoms and the Brief Psychiatric Rating Scale.

Secondary Outcome Measures

Craving
Craving will be assessed with the Marijuana Craving Questionnaire and a Visual Analog Craving Scale
Mood symptoms
Mood symptoms will be assessed with the Hamilton Depression Rating Scale
Adverse events
Adverse events will be assessed with the Systematic Assessment for Treatment Emergent Events interview, Simpson-Angus Scale for Extrapyramidal Symptoms, the Abnormal Involuntary Movement Scale, the Barnes Akathisia Scale, and blood tests (fasting glucose, insulin and lipid profile tests)

Full Information

First Posted
June 28, 2010
Last Updated
April 12, 2018
Sponsor
Northwell Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01153490
Brief Title
Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine
Acronym
CD
Official Title
Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 22, 2010 (Actual)
Primary Completion Date
August 6, 2012 (Actual)
Study Completion Date
August 6, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Cannabis is the most used illicit substance in the United States. Previous studies suggest that atypical antipsychotics decrease the frequency and the amount of substance use in subjects with and without psychotic illness. So far, there are no controlled studies assessing the effectiveness of atypical antipsychotics for decreasing cannabis and other substance use in individuals with cannabis use disorders. The investigators postulate that the atypical antipsychotic quetiapine ER is an effective agent for improving substance use outcomes in subjects with cannabis use disorders. In this pilot study, the investigators will test this hypothesis in heavy cannabis users (i.e., individuals who are cannabis dependent and smoke three times or more per week). Because 50% of these heavy cannabis users report histories of psychotic experiences (i.e., attenuated positive symptoms) while smoking and are at risk for recurring psychotic symptoms, the investigators will focus this pilot clinical trial on this subgroup of cannabis users in order to increase the risk/benefit ratio of this study and target a population that may also benefit from the antipsychotic effect of quetiapine ER. Considering the lack of controlled studies assessing the efficacy of atypical antipsychotics in heavy cannabis users, assessing the effectiveness of an atypical antipsychotic medication on substance use and clinical outcomes in this population is critical for improving the prognosis of these individuals. Thus, the aims of this randomized, double-blind, placebo-controlled study are to assess the efficacy of an atypical antipsychotic (quetiapine ER) in 120 subjects with cannabis dependence, a recent history (within a year) of attenuated psychotic symptoms, and using cannabis 3 times or more per week for: (1) decreasing the use of cannabis and other substances; and (2) preventing the recurrence of psychotic experiences. The investigators will also assess the effects of quetiapine ER on craving and mood, and its tolerability. This project will be a 12-week, randomized, double-blind, placebo-controlled study with quetiapine ER and it will include a comprehensive assessment of symptoms, substance use, and side effects. This study will benefit the field by providing unique data on the relative efficacy and tolerability of treatment with atypical antipsychotics in heavy cannabis users with a vulnerability to psychosis. This study will be the basis for future studies assessing the long-term efficacy and tolerability of atypical antipsychotics in individuals with cannabis use disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Dependence
Keywords
Quetiapine, Psychotic experiences, Cannabis dependence, Craving, Mood, Substance use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Quetiapine ER
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Intervention Description
Substance-related
Primary Outcome Measure Information:
Title
Frequency/amount of substance use
Description
frequency and amount of cannabis and other substance use will be recorded with the Timeline Follow-Back Method.
Time Frame
12 weeks
Title
Psychotic symptoms
Description
Psychotic symptoms wil be assessed with the Structured Interview for Prodromal Symptoms and the Brief Psychiatric Rating Scale.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Craving
Description
Craving will be assessed with the Marijuana Craving Questionnaire and a Visual Analog Craving Scale
Time Frame
12 weeks
Title
Mood symptoms
Description
Mood symptoms will be assessed with the Hamilton Depression Rating Scale
Time Frame
12 weeks
Title
Adverse events
Description
Adverse events will be assessed with the Systematic Assessment for Treatment Emergent Events interview, Simpson-Angus Scale for Extrapyramidal Symptoms, the Abnormal Involuntary Movement Scale, the Barnes Akathisia Scale, and blood tests (fasting glucose, insulin and lipid profile tests)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: DSM-IV-defined diagnosis of cannabis dependence (304.30) assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998)) one or more attenuated positive symptoms with a score 3 ('moderate'), 4 ('moderate severe'), or 5 ('severe but not psychotic') during the past year assessed with the Structured Interview for Prodromal Syndromes (SIPS) and the Scale of Prodromal Symptoms (SOPS) (McGlashan et al, 2001) lifetime treatment with antipsychotic medication less than 2 weeks cannabis use for more than one year cannabis use three or more days per week on average for the past 3 months aged 18 to 65 competent and willing to sign informed consent for women, a negative urine pregnancy test and agreement to use a medically accepted method of birth control during the study. Exclusion Criteria: DSM-IV criteria for schizophrenia, schizophreniform disorder, schizoaffective disorder, a psychotic disorder due to a general medical condition, psychosis NOS, delusional disorder, brief psychotic disorder, shared psychotic disorder, or a mood disorder (major depression or bipolar) with psychotic features assessed with the Structured Clinical Interview for Axis I DSM-IV Disorders (SCID-I/P) (First 1998) DSM-IV diagnosis of any psychoactive substance dependence other than cannabis or nicotine being in an environment with no access to cannabis (e.g., hospitalization, residential treatment, jail, ..) for more than one week during the past three months preceding study entry serious neurological or endocrine disorder or any medical condition or treatment known to affect the brain use of medications that have an effect on monoamines (e.g., antidepressants severe medical or physical illnesses criteria of the National Cholesterol Education Program (NCEP) for a metabolic syndrome (Expert panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults, 2001) medical condition that requires treatment with a medication that has psychotropic effects significant risk of suicidal or homicidal behavior cognitive or language limitations, or any other factor that would preclude subjects providing informed consent or participating in study procedures treatment with medications for addiction treatment with medication having a risk of addiction (e.g., benzodiazepines, barbiturates) history of treatment resistance to quetiapine ER medical contraindications to quetiapine ER hypersensitivity to quetiapine ER or any of its component for women, pregnant, breastfeeding, or intention to become pregnant during the study timeframe
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serge Sevy, M.D., MBA
Organizational Affiliation
Feinstein Institute for Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Zucker Hillside Hospital
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
General Clinical Research Center
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

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Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine

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